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Wellbutrin XL for Dysthymic Disorder
This study has been completed.
Study NCT00225251   Information provided by St. Luke's-Roosevelt Hospital Center
First Received: September 21, 2005   Last Updated: June 5, 2007   History of Changes

September 21, 2005
June 5, 2007
November 2004
 
Hamilton Depression Rating Scale, 24 items (HDRS) [ Time Frame: 10 weeks ]
Hamilton Depression Rating Scale, 24 items (HDRS)
Complete list of historical versions of study NCT00225251 on ClinicalTrials.gov Archive Site
  • Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ]
  • Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ]
  • Clinical Global Impressions (CGI) [ Time Frame: 10 weeks ]
  • Global Assessment of Functioning Scale (GAFS) [ Time Frame: 10 weeks ]
  • Patient-CGI (CGI-P) [ Time Frame: 10 weeks ]
  • Social Adjustment Scale (SAS) [ Time Frame: 10 weeks ]
  • Symptom Checklist (SCL-90-R) [ Time Frame: 10 weeks ]
  • Temperament and Character Inventory (TCI) [ Time Frame: 10 weeks ]
  • Medical Outcomes Study- HIV – Cognitive Scale (MOS-HIVcs) [ Time Frame: 10 weeks ]
  • Aldenkamp-Baker Neurotoxicity Scale (ABS) [ Time Frame: 10 weeks ]
  • Arizona Sexual Experiences Scale (ASEX) [ Time Frame: 10 weeks ]
  • Cornell Dysthymia Rating Scale (CDRS)
  • Beck Depression Inventory (BDI)
  • Clinical Global Impressions (CGI)
  • Global Assessment of Functioning Scale (GAFS)
  • Patient-CGI (CGI-P)
  • Social Adjustment Scale (SAS)
  • Symptom Checklist (SCL-90-R)
  • Temperament and Character Inventory (TCI)
  • Medical Outcomes Study- HIV – Cognitive Scale (MOS-HIVcs)
  • Aldenkamp-Baker Neurotoxicity Scale (ABS)
  • Arizona Sexual Experiences Scale (ASEX)
 
Wellbutrin XL for Dysthymic Disorder
Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL

This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

This is a ten-week, double-blind, placebo-controlled study designed to evaluate the tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet DSM-IV criteria for early onset, primary type dysthymic disorder (low-grade chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Dysthymic Disorder
Drug: bupropion XL
 
Hellerstein DJ, Batchelder S, Kreditor D, Fedak M. Bupropion sustained-release for the treatment of dysthymic disorder: an open-label study. J Clin Psychopharmacol. 2001 Jun;21(3):325-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
 

Inclusion Criteria:

  • Male and female outpatients 18-65 years of age.
  • Patients with a DSM-IV diagnosis of dysthymic disorder, early onset.
  • Patients will have a total score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.

Exclusion Criteria:

  • Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.
  • Patients who are pregnant or nursing women.
  • Patients with a principal diagnosis meeting DSM-IV criteria for: Major Depressive disorder, Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder
  • Patients who have a current or prior diagnosis of Anorexia Nervosa or Bulimia
  • Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.
  • Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:

    • Report of having a specific plan for killing themselves,
    • A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors), or
    • A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of > 1 week’s dose of medication).
  • Patients with a history of recurrent Grand Mal seizures or at risk of Grand Mal seizures, and those with other medical conditions in which Wellbutrin XL would be contraindicated, including a history of head trauma.
  • Use of any psychotropic medication within 1 week of starting study medication
  • Use of a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) within the 14 days prior to the initial dose of study medication.
  • Use of fluoxetine within 28 days of the initial dose of study medication.
  • Use of Zyban® or other forms of bupropion hydrochloride (i.e. Wellbutrin immediate release or Wellbutrin Sustained Release (SR)) within 2 weeks of the initial dose of medication.
  • Patients who have failed to respond to adequate trials (minimum of six consecutive weeks) of two different classes of antidepressant medication (see Table 1 for definitions of an adequate trial.)
  • Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic or neurologic disease, or any clinically significant laboratory abnormality.
  • Patients who have begun a course of psychotherapy within 3 months of starting the study, or who plan to terminate an ongoing psychotherapy prior to the end of the study.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00225251
 
gsk 102149
St. Luke's-Roosevelt Hospital Center
GlaxoSmithKline
Principal Investigator: David J. Hellerstein, MD St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute
St. Luke's-Roosevelt Hospital Center
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP